Health Canada, the Canadian regulating authority, has published a notice to the medical devices manufacturers, dedicated to the technical requirements for decontamination devices employing ultraviolet (UV) radiation. The scope of the document covers both decontamination devices intended to be placed on the market under the interim order authorization, or by the virtue of medical device license application.
It is also important to mention that the scope of the notice covers only the systems initially intended to decontaminate medical devices, including single-used ones, while any systems intended for decontamination of other (non-medical) objects, as well as the ones intended for disinfection purposes, are falling outside its scope.
Health Canada states the demand for UV-based decontamination systems has increased significantly during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus.” The aforementioned systems are vitally important since they could be used to decontaminate reusable medical devices and, in certain cases, even reprocess single-use medical devices (the ones initially intended to be used only once, for one procedure, and for only one patient).
First of all, the notice provides brief information about the types of ultraviolet rays. In particular, there are three types of them:
- UVB, and
The last ones have the shortest length of the wave, while the first and second are not suitable for decontamination of medical devices due to the relatively low energy.
The document also outlines the most important factors impacting the effectiveness of the decontamination procedures performed by the virtue of ultraviolet rays, namely:
- Exposure time,
- The wavelength of UV radiation.
Health Canada refers to the ultraviolet germicidal irradiation (UVGI) – the particular procedure to be performed in the course of decontamination to reach the intended purpose.
At the same time, the authority also mentions certain complications existing in the context of decontamination of medical devices by using the UV rays. For example, the actual level of the ultraviolet germicidal irradiation could be insufficient to ensure efficient decontamination, or the devices themselves could prevent effective decontamination due to some specifics of their design or construction. In some cases, the necessary level of UVGI could not be applied since it could harm the device itself.
Another important aspect to be considered in the context of the UV decontamination of medical devices is the concept of the line-of-sight exposure, under which the decontaminating effect could be achieved on the surfaces of the device directly exposed to the UV rays. That is why UV-based decontamination is quite often combined with other procedures, such as water and air decontamination in order to improve the overall effectiveness. The UV-based decontamination itself s the most effective when applied for medical devices manufactured of non-porous materials.
Health Canada also warns about specific safety-related aspects associated with the use of UV rays for decontamination purposes – the authority emphasizes that since the exposure to UV rays could be harmful to the human body, the decontamination devices based on this method should be designed as closed systems.
Decontamination (Reprocessing) of Single-Use Medical Devices
When describing the requirements to be applied in case of UV-based decontamination devices intended to be used for the reprocessing of single-use medical devices, the authority refers to the appropriate notice dedicated to the reprocessing of single-use filtering face-piece respirators, and also to the general requirements on reprocessing of single-use medical devices set forth by the Medical Devices Regulations.
UV-based Decontamination Devices: Regulatory Approach
According to the notice published by Health Canada, the products intended for low-level disinfection purposes do not fall within the scope of the definition of medical devices and, consequently, should not be regulated as medical devices. At the same time, the devices covered by the scope of the present notice are subject to regulation as medical devices due to their intended purpose – decontamination of medical devices. Such products should be assigned to Class II under the risk-based classification. As it was already mentioned before, in order to be allowed for marketing and use in Canada, UV-based decontamination devices should be subject to state authorization under one of the following frameworks:
- the interim order (IO) authorization, or
- applying for the medical device license.
The notice also contains references to the appropriate guidelines to be considered by medical device manufacturers for each regulatory pathway.
The authority also states that a few submissions have been already filed by the manufacturers under the IO framework. Nevertheless, up till now, Health Canada has not authorized any of such devices.
Requirements for UV-based Decontamination Devices
Health Canada also outlines the requirements UV-based decontamination devices should meet with regard to the safety and performance aspects. The authority also mentions that these requirements are the same as applied for similar devices in the US.
In this regard, it is important to notice that Health Canada actually finds low-level disinfection as inappropriate when it takes to reprocessing of single-use medical devices and personal protective equipment, such as face masks.
When applying for Health Canada`s approval under the interim order procedure, the medical device manufacturer (the applicant) shall supplement the submission with the appropriate information regarding performance testing and labeling.
In the context of performance testing, the regulating authority places an emphasis on the following aspects:
- The ultraviolet irradiation level should be significant enough to meet the pre-defined effectiveness endpoints, which should be demonstrated by providing the results of microbial challenge validation testing,
- The ultraviolet irradiation level should be sufficient to ensure effective decontamination of all sides of medical devices subject to the procedure, providing that the dark spaces caused by the elements preventing exposure to UV rays are reduced to the lowest extent possible and do not impact the overall performance and effectiveness of the UV-based decontamination system in question,
- The UV-emission level should not cause harm to medical devices being decontaminated – their characteristics and performance should remain the same,
- Aside from the aspects related to decontamination itself, the points to be considered include the ones related to electrical and mechanical safety, as well as electromagnetic compatibility.
Besides the points above, Health Canada also indicates the admissible level of the ozone emitted from the device.
The notice also addresses the issues related to the labeling of UV-based decontamination devices. According to the document, the labeling of such device shall contain the following elements:
- Warnings related to the risks associated with the ultraviolet radiation,
- Description of the operating procedures,
- Description of the preliminary actions to be performed with regard to medical devices subject to decontamination,
- Indication of validation microbes to be considered for validation purposes,
- Indication of medical devices that could be decontaminated by the virtue of the device in question.
Summarizing the information provided here above, the notice issued by Health Canada covers the most important aspects associated with decontamination systems based on ultraviolet radiation. The document describes the current regulatory approach, existing frameworks that could be followed when placing the device on the market, and also the safety and performance criteria to be applied for UB-based decontamination devices.
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